Performance of the ePrime System for Cellulite

NCT02489994 | Unknown

• 1 other identifier: DHF15911
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 4

Brief Summary

Clinical Study to Evaluate the Performance of the ePrime System for the Treatment of Cellulite.

Conditions

Cellulite

Outcome Measures

Primary Outcomes (1)

• Improvement in cellulite compared to baseline for the upper thighs and buttocks, as assessed by blinded evaluation of clinical photographs

  Evaluate the efficacy of a single dermal and subcutaneous treatment with ePrime for the upper thighs and buttocks cellulite as assessed by blinded evaluators at 3 months post treatment visit.

  Baseline and 3 months post treatment visit

Secondary Outcomes (5)

• Improvement in cellulite compared to baseline for the upper thighs and buttocks, as assessed by blinded evaluation of clinical photographs

  Baseline and 6 months post treatment visit

• Number of Participants with Adverse Events

  day 0 up to 7 months

• Improvement in cellulite compared to baseline

  Baseline, 1 month, 3 and 6 months post treatment visit.

• Investigator satisfaction - by questionnaire

  1, 3, and 6 months post-treatment visit

• Subject satisfaction - by questionnaire

  1, 3, and 6 months post-treatment visit

Study Arms (1)

all subjects

EXPERIMENTAL

Treatment with the ePrime radiofrequency microneedling device in the upper thighs and buttocks

Device: ePrime

Interventions

ePrime DEVICE

The main intent of the ePrime for cellulite is to utilize a minimally-invasive approach to directly deliver RF energy into tissue through pairs of micro-electrode needles and use temperature sensors within the needles to reliably create fractional thermal injuries within the skin.

all subjects

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects seeking treatment of cellulite in the upper thighs and buttocks areas.
• Subject have cellulite stage II or III as graded using Nurnberger-Muller scale clasification (Appendix III)
• Healthy female subjects ages 25 to 60 years of age
• Informed consent process completed and subject signed consent
• Willing to receive the proposed ePrime treatment and follow-up protocol
• Not pregnant or lactating and must be either post-menopausal, surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment (i.e., oral contraceptives, contraceptive implant, barrier methods with spermicide or abstinence)
• Willing to have photographs taken of the treated areas to be used de-identified in evaluations, publications and presentations

You may not qualify if:

• Subject had surgery or any other procedure for cellulite in the last 6 months
• Pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breast feeding
• Known allergy to lidocaine or epinephrine or antibiotics
• Active malignancy or history of malignancy in the past 5 years
• Having any active electrical implant anywhere in the body, such as a pacemaker or an internal defibrillator
• Suffering from significant concurrent illness, such as cardiac disorders, diabetes (type I or II), lupus, porphyria, or pertinent neurological disorders (i.e. any disease state that in the opinion of the Physician would interfere with the anesthesia, treatment, or healing process)
• History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications
• Suffering from hormonal imbalance, whether related to thyroid, pituitary, or androgen
• History of significant lymphatic drainage problems
• History of cancer which required lymph node biopsy or dissection
• Suffering from significant skin conditions in the treated areas or inflammatory skin conditions, including, but not limited to, open lacerations or abrasions, hidradenitis, or dermatitis of the treatment area prior to treatment (duration of resolution as per the Investigator's discretion) or during the treatment course
• History of keloid scarring, abnormal wound healing and / or prone to bruising
• History of epidermal or dermal disorders (particularly if involving collagen or microvascularity), including collagen vascular disease or vasculitic disorders
• Use of isotretinoin (Accutane®) within 6 months of treatment or during the study
• Subject on systemic corticosteroid therapy 6 months prior to and throughout the course of the study

Sponsors & Collaborators

• Syneron Medical: lead

Study Sites (4)

Bowes Leyda

Miami, Florida, 33133, United States

Location

David Goldberg

Hackensack, New Jersey, 07601, United States

Location

Macrene Alexiades

New York, New York, 10028, United States

Location

Girish Munavalli

Charlotte, North Carolina, 28270, United States

Location

Related Publications (2)

• Rawlings AV. Cellulite and its treatment. Int J Cosmet Sci. 2006 Jun;28(3):175-90. doi: 10.1111/j.1467-2494.2006.00318.x.

  PMID: 18489274 BACKGROUND

• Rossi AB, Vergnanini AL. Cellulite: a review. J Eur Acad Dermatol Venereol. 2000 Jul;14(4):251-62. doi: 10.1046/j.1468-3083.2000.00016.x.

  PMID: 11204512 BACKGROUND

MeSH Terms

Conditions

Cellulite

Condition Hierarchy (Ancestors)

Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Macrene Alexiades, MD

  Dermatology and Laser Surgery Center 955 Park Avenue, New York, NY, 10028

  PRINCIPAL INVESTIGATOR

• Leyda Bowes, MD

  Bowes Dermatology, 3659 South Miami Avenue, Suite # 6008, Miami, FL 33133

  PRINCIPAL INVESTIGATOR

• David Goldberg, MD

  Skin Laser & Surgery Specialist of NY/NJ

  PRINCIPAL INVESTIGATOR

• Girish Munavalli, MD

  Laser & Vein Specialists of the Carolinas, 1918 Randolph Road, Suite 550, Charlotte, NC 28270

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2015
• First Posted: July 3, 2015
• Study Start: October 1, 2014
• Primary Completion: August 1, 2016
• Study Completion: October 1, 2016
• Last Updated: March 18, 2016

Record last verified: 2016-03

Locations

US (4)